drugset
drugset / Trial / NCT05186285

Single Ascending Dose Study of CM338 in Healthy Volunteers

NCT05186285 ↗

Phase 1 Completed 66 enrolled Keymed Biosciences Co.Ltd
RandomizedSequentialQuadruple-blindTreatment

Summary

This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.

Timeline

Start
2021-12-11
Primary completion
2022-07-27
Completion
2022-07-27

Drugs

EvaluationDrugModalityDoseRoute
Subject CM338 Monoclonal antibody 30 mg Intravenous
Subject CM338 Monoclonal antibody 60 mg Intravenous
Subject CM338 Monoclonal antibody 120 mg Intravenous
Subject CM338 Monoclonal antibody 240 mg Intravenous
Subject CM338 Monoclonal antibody 480 mg Intravenous
Subject CM338 Monoclonal antibody 600 mg Intravenous

Indications

No indication recorded.